MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SMART COIL; HCG, KRD

Catalog Number	400SMTXSFT2H06
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.There was no secondary shape to the embolization coil upon the initial advancement of the smart coils out of their introducer sheaths.After lightly shaking the embolization coils, the coils relaxed and the secondary shapes were present.Conclusions: evaluation of the returned devices revealed that the smart coils secondary shape was not present after the initial advancement out of their introducer sheaths.After advancing out of the introducer sheaths and lightly shaking the embolization coils, the coils relaxed and the secondary shape were present.The root cause of the reported issue may have been related to excess tension within the embolization coils; however, once the tension was released, the coils functioned as intended.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra smart coils (smart coils).During the procedure, the physician found that the smart coil had no shape as it was advanced out of the non-penumbra microcatheter to be placed in the patient; therefore, the smart coil was removed.The procedure was ended after attempting to place additional coils, though no coils were successfully placed due to the shape of the aneurysm.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6726645
• Report Number: 3005168196-2017-01226
• Device Sequence Number: 832133
• Product Code: HCG
• UDI-Device Identifier: 00814548015330
• UDI-Public: 00814548015330
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/13/2021
• Device Catalogue Number: 400SMTXSFT2H06
• Device Lot Number: F72856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR